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510(k) K880099

VAN-TEC BLADDER EVACUATOR by Van-Tec, Inc. — Product Code KQT

K880099 is an FDA 510(k) premarket notification submitted by Van-Tec, Inc. for the device "VAN-TEC BLADDER EVACUATOR". The FDA issued a decision of Substantially Equivalent on March 2, 1988. The device falls under product code KQT (Evacuator, Gastro-Urology), a Class II device regulated under 21 CFR 876.4370. Van-Tec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1988
Date Received
January 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Evacuator, Gastro-Urology
Device Class
Class II
Regulation Number
876.4370
Review Panel
GU
Submission Type

Other clearances by Van-Tec, Inc.

  • K880096 — VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP (March 2, 1988)
  • K880098 — VAN-TEC AUTO BIOPSY NEEDLE (March 2, 1988)
  • K880095 — BERGER PROSTATE CULTURE CYTOLOGY BRUSH (March 2, 1988)
  • K880094 — VAN-TEC ENDOPYELOTOMY KNIFE (February 29, 1988)
  • K874112 — VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER (February 11, 1988)
  • K871779 — HELICAL STONE BASKET (DISPOSABLE) (June 17, 1987)
  • K871777 — VAN-TEC REUSABLE HELICAL STONE BASKET (June 17, 1987)
  • K870557 — VAN-TEC PUMPING SYSTEM (March 30, 1987)
  • K870696 — VAN-TEC SEGURA STONE BASKET W/PROTECTIVE SHEATH (March 30, 1987)
  • K870679 — VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE (March 30, 1987)

Other clearances for product code KQT

  • K964111 — LITHOVAC SUCTION/ASPIRATION PROBE (December 16, 1996)
  • K921088 — EVACUATOR, GASTRO-UROLOGY (October 28, 1992)
  • K921451 — EVACUATOR, GASTRO-UROLOGY (October 28, 1992)
  • K910728 — CLEANFLOW SYSTEM (April 1, 1991)
  • K874493 — BELLA - VAC IRRIGATOR (February 5, 1988)
  • K860266 — ELLIK EVACUATOR (March 5, 1986)
  • K830546 — DOSIMETRIC RELEASE (May 25, 1983)
  • K811779 — ROSS-EMERSON PUMP, MODEL 55-R (July 13, 1981)
  • K810739 — SUCTION WOUND DRAINAGE DEVICE (June 26, 1981)
  • K801781 — CATHETER IRRIGATION SYRINGES, #3100,3110 (August 13, 1980)

FDA data resources